General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Post-traumatic Stress Disorder Clinical Trial

Official title:

A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD and Co-Morbidities in Healthcare Workers Consequent to the COVID-19 Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626050
• Other study ID #: 20-04021913
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: April 2025

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: Olivia Baryluk, BS
• Phone: 212-821-0783
• Email: olb4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any healthcare worker providing medical care or support for COVID-19 patients
• English-speaking
• Age >18
• Medically stable
• Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
• If on psychotropic medication stable for prior 60 days

For phase II additional inclusion criteria:

• Current diagnosis of PTSD

Exclusion Criteria:

• Current significant unstable medical illness precluding regular session attendance or assessment completion
• Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk
• Lifetime or current diagnosis of schizophrenia or other psychotic disorder
• Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.

Related Conditions & MeSH terms

• COVID-19
• Moral Injury
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Medical Music
Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
• Narrative Writing
Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
• Prolonged Exposure Therapy
Psychotherapy including imaginal exposure for PTSD
• Interpersonal Psychotherapy
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Indicator: Recruitment (Phase I)	Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.	Baseline
Primary	Feasibility Indicator: Recruitment (Phase II)	Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.	Post-Phase I Assessment at week 2
Primary	Feasibility Indicator: Enrollment (Phase I)	Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.	Baseline
Primary	Feasibility Indicator: Enrollment (Phase II)	Feasibility assessment will include enrollment defined as number of individuals beginning phase II.	Post-Phase I Assessment at approximately week 2
Primary	Feasibility Indicator: Retention (Phase I)	Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.	Post-Phase I Assessment at approximately week 2
Primary	Feasibility Indicator: Retention (Phase II)	Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.	Post-Phase II Assessment at approximately week 7
Primary	Acceptability Indicator: Satisfaction (Phase I)	Acceptability and treatment satisfaction will be rated with a Likert scale.	Post-Phase I Assessment at approximately week 2
Primary	Acceptability Indicator: Satisfaction (Phase II)	Acceptability and treatment satisfaction will be rated with a Likert scale.	Post-Phase II Assessment at approximately week 7
Primary	Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.	Start of Phase I to approximately 2 weeks
Primary	Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.	Start of Phase II to approximately 5 weeks
Secondary	Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)	Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety; Higher scores indicate greater symptom severity.	Start of Phase I to approximately 2 weeks
Secondary	Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)	Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety; Higher scores indicate greater symptom severity.	Start of Phase II to approximately 5 weeks
Secondary	Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)	16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity	Start of Phase I to approximately 2 weeks
Secondary	Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)	16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)	24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)	24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)	11 item self-report measure measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)	11 item self-report measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Modified Moral Injury Events Scale (Phase I)	11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Modified Moral Injury Events Scale (Phase II)	11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)	The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)	The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Sheehan Disability Scale (SDS) (Phase I)	10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Sheehan Disability Scale (SDS) (Phase II)	10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)	The minimum score is 0 and the maximum score is 100. High score shows better result.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)	The minimum score is 0 and the maximum score is 100. High score shows better result.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)	5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)	5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.	Start of Phase II to approximately 5 weeks
Secondary	Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)	The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.	Start of Phase I to approximately 2 weeks
Secondary	Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)	The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.	Start of Phase II to approximately 5 weeks
Secondary	Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)	12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.	Start of Phase I to approximately 2 weeks
Secondary	Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)	12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Posttraumatic Cognitions Inventory (Phase I)	33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Posttraumatic Cognitions Inventory (Phase II)	33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)	The Difficulties in Emotion Regulation Scale-18 (DERS) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)	The Difficulties in Emotion Regulation Scale-18 (DERS-18) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.	Start of Phase II to approximately 5 weeks
Secondary	Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)	The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.	Start of Phase I to approximately 2 weeks
Secondary	Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)	The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.	Start of Phase II to approximately 5 weeks